Hematopoietic and Lymphoid Cell NeoplasmEarly Phase 1NCT06184321
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
A Early Phase 1 study testing Alteplase in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Alteplase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Aug 2023to 2 Feb 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral to pulmonary services for inability to drain fully via IPC
- Presence of a symptomatic septated pleural effusion
- A pleural effusion of significant moderate to large volume based on:
- Chest radiograph: effusion filling >= 1/3 of the hemithorax, or
- Computed tomography (CT)-scan: AP depth of the effusion >= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or
- Ultrasound: effusion spanning at least three intercostal spaces, with a >= 3 cm in at least one intercostal space, while the patient sits upright
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- Age > 18
- Borg score >= 3
- Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
- Presence of septated effusion based on ultrasound (US) and chest CT
Who cannot join
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.
- Active bleeding
- Known allergic reaction to thrombolytics
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
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- No septations and/or no loculations on bedside pre-procedure ultrasound
- Patient is asymptomatic
- Blocked IPC as determined by saline flush
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
John Hopkins University
Baltimore, Maryland, 21287
Jeffrey Thiboutot, MD, 410-502-2533, jthibou1@jhmi.edu
Jeffrey Thiboutot, MD
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Horiana Grosu, MD, 713-792-6238, hbgrosu@mdanderson.org
Horiana Grosu, MD
About this study
Official title: A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC).
SECONDARY OBJECTIVE:
- To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.
- Being tested
- Alteplase, Placebo Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseBiological
Also called Activase, Plasminogen Activator (Human Tissue-Type Protein Moiety), r-tPA, Recombinant Tissue Plasminogen Activator
Instilled into IPC
Placebo AdministrationDrug
Instilled into IPC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (alteplase) | Experimental | Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Receives: Biological: Alteplase |
| Arm II (placebo) | Placebo comparator | Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I. Receives: Drug: Placebo Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start17 Aug 2023
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horiana Grosu, M D, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184321
- Sponsor's protocol ID
- 2021-0554
- Other IDs
- NCI-2021-09122, 2021-0554
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No